Global Phase III trial has enrolled and randomised over 170 patients, reaching an important milestone as this is above the amount needed to conduct the futility analysisOver 100 clinical sites across 24 countries now activated and open for recruitment Futility analysis remains on track for completion in the first quarter of CY2026 SYDNEY, AUSTRALIA, Oct. 09, 2025 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) (“Immutep” or “the Company”), a late-stage immunotherapy company targeting cancer and ...

Core Viewpoint - Immutep Limited is advancing its clinical-stage biotechnology programs focused on LAG-3 immunotherapies for cancer and autoimmune diseases, with significant progress in multiple trials and a strong financial position as of June 30, 2025 [2][21]. Oncology Development Program - The TACTI-004 Phase III trial for advanced non-small cell lung cancer (NSCLC) is ongoing, with 78 sites across 23 countries activated for patient recruitment [3][4]. - The trial evaluates eftilagimod alfa (efti) in combination with KEYTRUDA® and chemotherapy, aiming to randomize approximately 756 patients [4]. - Immutep reported a 60.8% response rate and a 90.2% disease control rate in the INSIGHT-003 Phase I trial for non-squamous 1L NSCLC [6]. - In patients with TPS <50%, the triple combination achieved a 59.6% response rate compared to a historical control of 40.8% [7][8]. - The TACTI-003 Phase IIb trial for head and neck cancer showed a median overall survival of 17.6 months, outperforming historical standards of care [9][10]. - The EFTISARC-NEO Phase II trial for soft tissue sarcoma met its primary endpoint, significantly exceeding historical data for tumor hyalinization/fibrosis [12][13]. Autoimmune Disease Development Program - The Phase I trial of IMP761, a LAG-3 agonist antibody, demonstrated significant T cell suppression with a favorable safety profile at a dosing level of 0.9 mg/kg [16][17]. - Initial pharmacodynamic data indicated an 80% reduction in T cell activity, highlighting the potential efficacy of IMP761 in treating autoimmune diseases [18]. Intellectual Property - Immutep was granted four new patents during the quarter, including two for efti in combination with a PD-1 pathway inhibitor and two for IMP761 [19]. Corporate & Financial Summary - The company appointed Stephan Winckels as Chief Medical Officer, bringing over 15 years of oncology drug development experience [20]. - As of June 30, 2025, Immutep reported a cash position of approximately A$129.69 million, exceeding budget expectations [22]. - The net cash used in R&D activities during the quarter was A$15.66 million, reflecting increased clinical trial activities [23].

The Trial in Progress poster includes an overview and study design of the TACTI-004 Phase III evaluating the Company's antigen presenting cell (APC) activator, eftilagimod alfa (efti) in combination with MSD's (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 KEYTRUDA® (pembrolizumab) and chemotherapy as first line therapy for patients with advanced or metastatic non-small cell lung cancer (1L NSCLC). The global trial will enrol approximately 750 patients regardless of PD-L1 expression (Tumour Proportion Score ...

Core Insights - Immutep Limited, a late-stage immunotherapy company, announced that three abstracts for clinical trials of its MHC Class II agonist, eftilagimod alfa, have been accepted for presentation at the ESMO Congress 2025 in Berlin, Germany [1][2]. Group 1: Clinical Trials and Presentations - A Proffered Paper oral presentation will detail results from the EFTISARC-NEO Phase II trial in resectable soft tissue sarcoma, scheduled for October 19, 2025 [2]. - Data from the INSIGHT-003 Phase I trial in first-line non-small cell lung cancer (1L NSCLC) will be presented as a poster on October 18, 2025 [2]. - An abstract on the pivotal TACTI-004 Phase III trial in 1L NSCLC has been accepted for a Trials in Progress ePoster presentation [2]. Group 2: Company Overview - Immutep is focused on developing novel immunotherapies for cancer and autoimmune diseases, particularly leveraging the LAG-3 pathway to stimulate or suppress immune responses [4]. - The company aims to provide innovative treatment options and maximize shareholder value through its diversified product portfolio [4].

Core Insights - Immutep Limited's investigator-initiated EFTISARC-NEO Phase II trial has successfully met its primary endpoint, demonstrating a significant increase in tumour hyalinization/fibrosis in patients with resectable soft tissue sarcoma (STS) when treated with eftilagimod alfa (efti) combined with radiotherapy and KEYTRUDA® [1][7]. Company Overview - Immutep is a late-stage biotechnology company focused on developing innovative immunotherapies for cancer and autoimmune diseases, particularly leveraging the Lymphocyte Activation Gene-3 (LAG-3) pathway [7]. - The company is pioneering the understanding and advancement of therapeutics related to LAG-3, aiming to provide novel treatment options for patients and maximize shareholder value [7]. Trial Details - The EFTISARC-NEO trial showed a median of 50% tumour hyalinization/fibrosis in a preliminary analysis of 21 patients, significantly exceeding the prespecified median of 35% [3]. - The trial is primarily funded by a grant from the Polish government, with a total enrollment of 40 patients completed in January 2025 [3][4]. Medical Significance - Tumour hyalinization/fibrosis serves as an early surrogate endpoint linked to improved overall survival and recurrence-free survival in STS patients [2]. - STS is classified as an orphan disease with a high unmet medical need and poor prognosis, with an estimated 13,520 new cases and 5,420 deaths in the U.S. in 2025 [4]. Eftilagimod Alfa (efti) Profile - Efti is a proprietary soluble LAG-3 protein and MHC Class II agonist that stimulates both innate and adaptive immunity, enhancing the immune response against cancer [5]. - Efti is under evaluation for various solid tumours, including non-small cell lung cancer and head and neck squamous cell carcinoma, and has received Fast Track designation from the FDA for certain indications [6].

Core Insights - Immutep Limited has reported a median Overall Survival (OS) of 17.6 months in Cohort B of the TACTI-003 Phase IIb trial for patients with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) with PD-L1 expression below 1 [1][2] Group 1: Clinical Trial Results - The 17.6-month median OS in evaluable patients (N=31) is significantly better than historical results from standard-of-care treatments, which include 10.7 months from cetuximab + chemotherapy, 11.3 months from anti-PD-1 therapy + chemotherapy, and 7.9 months from anti-PD-1 monotherapy [2] - Efti in combination with pembrolizumab has shown a high overall response rate with multiple complete responses, indicating a promising efficacy profile [4][5] Group 2: Unmet Medical Need - Patients with CPS <1 in 1L HNSCC represent a high unmet medical need, as up to 20% of these patients lack approved immunotherapy-only treatment options [3][6] - The combination of efti and pembrolizumab addresses this gap, as current treatments for this population typically involve chemotherapy [3][6] Group 3: Safety and Regulatory Path - The combination therapy continues to be well-tolerated with no new safety signals reported, reinforcing its potential as a viable treatment option [4] - Immutep has requested a meeting with the U.S. FDA to discuss potential paths to approval for efti in 1L HNSCC with PD-L1 CPS <1, following its Fast Track designation [7][10] Group 4: About Efti - Efti is a proprietary soluble LAG-3 protein that stimulates both innate and adaptive immunity, enhancing the immune response against cancer [8] - The drug is under evaluation for various solid tumors, including non-small cell lung cancer and metastatic breast cancer, highlighting its broad therapeutic potential [9] Group 5: Company Overview - Immutep is a late-stage biotechnology company focused on developing novel immunotherapies for cancer and autoimmune diseases, leveraging its expertise in LAG-3 [11]